Sr. Director / Director CMC Lead

WuXi XDC; California; On-site; USD 170,000 - 250,000; Full time

Job summary

WuXi XDC seeks a senior CMC Lead to drive project and portfolio leadership from proposal through completion. You will interact with clients, technical teams, and business development while guiding ADC/bioconjugate CMC activities.

The role emphasizes collaboration, strategic planning, and delivering high-quality results. The ideal candidate has a PhD with 10+ years in pharma/biotech, strong communication skills in English and Mandarin, and a track record in CMC process development and/or GMP

Qualifications

• PhD required with 10+ years in pharma/biotech r&d, CMC or manufacturing.
• Strong project management and cross-functional leadership capabilities.
• Fluent in English and Mandarin Chinese.
• Experience with ADC/bioconjugates or large-molecule development is preferred.

Responsibilities

• Lead project and portfolio management from proposal to delivery.
• Coordinate with CMC, regulatory, and manufacturing teams to meet timelines and budgets.
• Engage with clients and BD team to promote WuXi XDC services.
• Oversee development and manufacturing strategy for ADC/bioconjugate projects.
• Facilitate alignment between WuXi XDC and client expectations.
• Mentor and guide team members to ensure quality and compliance.

Skills

Project management

Cross-functional collaboration

Problem solving

Interpersonal skills

Education

PhD in biochemistry/biochemical engineering/pharmaceutical science

Tools

MS Office

Job description

WuXi XDC (stock code: 2268.HK), a leading Contract Research, Development and Manufacturing Organization (CRDMO) focused on the global antibody drug conjugates (ADCs) and broader bioconjugate market, is a pioneering CRDMO offering integrated, end-to-end services. Services are provided from proximately located, state-of-the-art laboratories and manufacturing facilities, allowing for a significant reduction in development timelines and costs. Headquarter in Shanghai, China, our over 1,000 skilled employees work across a global network to deliver expert-driven, high-quality and right-first-time project execution for our customers. By offering a single-source, open-access platform with the most comprehensive capabilities and technologies, WuXi XDC enables our biopharmaceutical partners to speed the development of innovative therapies for the benefit of patients worldwide.

About the job

Summary:

The incumbent will lead the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical teams and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting WuXi XDC’s services at conferences/trade shows.

This position will offer the candidate flexibility working remotely from home in US west,preferred areas like SF， LA.

Responsibilities:

• Provide project and portfolio leadership supporting IND-enabling early and late stage bioproduct development CMC activities.
• Collaborate with CMC functional areas to ensure successful execution of various ADC or bioconjugate CMC projects, and delivery of results on time and within budget.
• Assist with development and manufacturing alliance management, product development and manufacturing strategy.
• Coordinate efforts and facilitate communication to ensure alignment between WuXi XDC and clients.
• Work with a high-performance team to ensure best quality services.
• Enhance current service offering and develop new clients.

Technical Skills /Knowledge:

The candidate should possess strong and effective project management, problem solving and interpersonal skills, and have a proven track record of working cross-functionally, across a wide variety of technical, business, and operational areas.

Demonstrate good understanding of the pharmaceutical industry and large molecule drug development.

• The title of this CMC Lead position is flexible and may be from Director up to Senior Director.
• Depending upon the title, minimal 15-20 years of relevant pharmaceutical or biotech industry experience in CMC process development and/or GMP manufacturing is required.
• Working knowledge and understanding of current regulations and industry trends for large molecule and ADC/bioconjugate product development, manufacture, and testing is a must.
• Working experience in ADC is preferred.
• Experience in a Contract Research Organization (CRO) or Contract Manufacturing Organization (CMO) is preferred, but not required.

Customary Education and Experience:

• PhD in biochemistry, molecular biology, biochemical engineering, pharmaceutical science or related discipline with 10+ working experience
• Experience in late stage and portfolio account management is a plus
• Strong Communication Skill
• Fluent in English and Mandarin Chinese.
• Must have working knowledge of MS Office products.
• Technical experience at large pharma or biotech companies.
• ADC/Biologics process/formulation/analytical development and/or manufacturing experience